PREdiabetes GLycemic Impact and Data Evaluation

Summary

This prospective, randomized controlled trial evaluates whether real-time continuous glucose monitoring (CGM) improves glycemic control and lifestyle adherence in adults with prediabetes compared to conventional self-monitoring methods over a 3-month period. By analyzing metabolic markers and behavioral data, the study aims to determine the effectiveness of 24-hour monitoring as a personalized tool that increases patient adherence to lifestyle changes compared to conventional SMBG methods.

Eligibility

Inclusion Criteria:

* Age of 18 years and older.
* Presence of prediabetes diagnosed according to criteria of the American Diabetes Association
* Persons who treated with diet and exercise alone or metformin on a stabilized dose for at least 3 months before the study;
* Ability to comply with protocol requirements and maintain a patient diary.
* Signed informed consent.

Exclusion Criteria:

* Presence of type 1 or type 2 diabetes;
* Decompensated liver or kidney diseases (GFR \< 45 ml/min/1. 73 m²);
* Active cardiovascular diseases within 12 months of Visit 1, such as myocardial infarction, clinically significant arrhythmia, unstable angina, coronary artery bypass surgery, or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study;
* Endocrine disorders (e.g., Itsenko-Cushing syndrome, acromegaly) that affect glycemia;
* Pregnancy or lactation;
* Mental or cognitive impairments that would interfere with study participation;
* Daily use of any form of steroid medication (oral, inhaled, injected) within the last 3 months;
* Recent use of any CGM within the last 12 months;
* Known allergy to sensor materials;
* Has evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator's opinion, would cause the individual to be noncompliant;
* Participation in another clinical study within the last 3 months.

Conditions4

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